Co Diovan (Valsartan HCT) - Uses, Dose, Side effects

Co Diovan is a combination of Valsartan and Hydrochlorothiazide (a combination of angiotensin receptor blocker and a thiazide diuretic). It is available as 80/12.5 and 160/12.5 mg for the treatment of hypertension.

Indications of Valsartan and Hydrochlorothiazide (Co Diovan):

  • Hypertension:

    • It is indicated for the management of hypertension (as a first-line, add-on, or as a substitute for titrated components)

Valsartan hydrochlorothiazide (Co Diovan) dose in adults:

Co Diovan dose in the treatment of Hypertension:

Note: Individual doses are used. When single medications are ineffective or when patients are maintained on both agents independently, it is administered as a first-line treatment option or as a replacement for individual components.

  • Initial therapy:

    • Once daily, take valsartan 160 mg/hydrochlorothiazide 12.5 mg orally and titrate as necessary based on the patients' responses after 1–2 weeks of treatment.
  • Maximum daily  dose:

    • Valsartan 320 mg per hydrochlorothiazide 25 mg.
  • Add-on/ replacement therapy:

    • Once daily, take valsartan 80 to 320 mg and hydrochlorothiazide 12.5 to 25 mg; titrate as necessary based on the patient's reaction after 3 to 4 weeks of treatment.
  • Maximum daily dose:

    • Valsartan 320 mg/hydrochlorothiazide 25 mg.

Valsartan Hydrochlorothiazide (Co Diovan) use in children:

The safety and efficacy of the drug in children have not been established.

Pregnancy Risk Category: D

[US Boxed Warning]

  • This is not advised since the medicine may harm or kill the foetus during pregnancy.
  • If you become pregnant, it should be stopped immediately
  • Also, see the individual agents (Valsartan and Hydrochlorothiazide).

Co Diovan use during breastfeeding:

  • Breast milk contains hydrochlorothiazide. It is unknown what happens to valsartan in breast milk.
  • Manufacturers do not recommend breastfeeding due to the potential for adverse effects on the fetus.
  • Talk to individual agents.

Valsartan and Hydrochlorothiazide (Co Diovan) Dose adjustment in renal disease:

  • If Creatinine clearance ≥30 mL/minute:

    • Dosage adjustment is not required.
  • If Creatinine clearance <30 mL/minute:

    • In patients with anuria, it is not advised.
    • In patients with CrCl of less than 30 ml/min, the manufacturer does not advise any dosage adjustments.

Valsartan and Hydrochlorothiazide dose in liver disease:

  • Mild to moderate impairment:

    • Dose adjustment is not required but caution must be used.
    • The exposure to valsartan in patients with mild to moderate chronic diseases is double that of healthy volunteers.
  • Severe impairment:

    • There are no dosage adjustments provided in the manufacturer’s labeling.

Common Side Effects of Valsartan and hydrochlorothiazide (Co Diovan):

  • Renal:

    • Increased blood urea nitrogen

Less Common Side Effects of Valsartan and hydrochlorothiazide (C0 Diovan):

  • Cardiovascular:

    • Hypotension
  • Central Nervous System:

    • Dizziness
  • Endocrine & Metabolic:

    • Hypokalemia
  • Renal:

    • Increased Serum Creatinine
  • Respiratory:

    • Nasopharyngitis

Rare Side effects of Valsartan and Hydrochlorothiazide (Co Diovan):

  • Cardiovascular:

    • Chest Pain
    • Orthostatic Hypotension
    • Palpitations
    • Peripheral Edema
    • Tachycardia
  • Central Nervous System:

    • Anxiety
    • Drowsiness
    • Fatigue
    • Insomnia
    • Paresthesia
    • Vertigo
  • Dermatologic:

    • Hyperhidrosis
    • Skin Rash
  • Gastrointestinal:

    • Abdominal Pain
    • Diarrhea
    • Dyspepsia
    • Flatulence
    • Nausea
    • Vomiting
    • Xerostomia
  • Genitourinary:

    • Pollakiuria
  • Infection:

    • Infection
  • Neuromuscular & Skeletal:

    • Arthralgia
    • Myalgia
    • Weakness
  • Otic:

    • Tinnitus
  • Respiratory:

    • Cough
    • Dyspnea
  • Miscellaneous:

    • Fever

Contraindication to Valsartan and hydrochlorothiazide:

  • Hypersensitivity to any ingredient in the formulation, including hydrochlorothiazide, valsartan, and medications derived from sulfonamides.
  • Anuria
  • Combination therapy with aliskiren in patients with diabetes mellitus
  • Pregnancy,
  • Breastfeeding
  • Hyponatremia and hypercalcemia
  • Hyperuricemia
  • Hypokalemia can result from certain conditions
  • Grave progressive renal disease
  • Treatment can lead to an increase in azotemia or oliguria.
  • For individuals with moderate or severe renal impairment (GFR 60mL/min/1.73m2), combination therapy with Aliskiren is recommended.

Notice:

  • Although the FDA-approved product labelling warns that this medication should not be taken with other groups of drugs that contain sulfonamides, the scientific validity of this claim has been questioned.
  • See "Warnings/Precautions" for more detail.

Warnings and precautions

  • Angioedema

    • Angiotensin II receptor inhibitors (ARBs), can cause angioedema during any treatment.
    • It might affect the bowel, neck (perhaps restricting your airway), or head (possibly causing abdominal pain).
    • Patients who have genetic, idiopathic, or other types of angioedema are more vulnerable.
    • Regular monitoring is necessary in the event of involvement of the tongue, glottis or larynx. This is especially true if there has been any previous airway surgery.
    • In the event of angioedema, therapy should be stopped immediately. Intramuscular epinephrine should also be administered.
    • Patients with angioedema caused by ARBs should not be used.
  • Electrolyte disturbances:

    • Hyperkalemia can be caused by ARBs. Therefore, caution and close monitoring are advised.
    • Renal failure, potassium-sparing diuretics, potassium supplements, and potassium-containing salts all raised the chance of developing DM.
    • Hypokalemia, hypochloremic acidosis, hypomagnesemia and hyponatremia can all be caused by Thiazide diuretics.
  • Gout

    • Gout can be caused by hydrochlorothiazide, especially if the dose is greater than 25 mg
    • Patients with chronic renal disease, history of gout, or a family history of gout are at greater risk.
  • Hypersensitivity reactions

    • Hypersensitivity reactions to HYdrochlorothiazide may occur in patients who have had a history of asthma or allergy.
  • Hypotension

    • Hypotension is common in patients who have had heart surgery or are recovering from a previous MI.
    • Patients with salt- and volume-depletion (eg those who have been treated with high dose diuretics) are at greater risk. Therefore, volume correction before starting treatment is recommended.
    • Further valsartan/hydrochlorothiazide treatment is not contraindicated by this temporary hypotensive response.
  • Ocular effects

    • Early hydrochlorothiazide therapy can lead to acute transient myopia or angle-closure glaucoma.
    • Patients suffering from severe visual impairments or ocular pain should not be treated.
    • Penicillin allergy or sulfonamide allergy can increase the risk.
    • If intraocular pressure is not controlled, additional treatments may be required.
  • Photosensitivity

    • Photosensitization can occur.
  • Renal function deterioration:

    • Creatinine levels can be raised in the initial therapy.
    • Therapy can lead to deranged renal function, including oliguria and acute renal failure in patients with low renal blood flow.
    • If there is significant deterioration, it is best to stop the therapy.
  • Allergy to sulfonamide ("sulfa")

    • Wide-ranging contraindications for patients who have previously experienced an allergic reaction to sulfonamides are listed on the FDA-approved product labels for drugs that contain these chemical groups.
    • Cross-reactivity is possible with any two antibiotic sulfonamides.
    • Cross-reactivity concerns have been raised previously for all compounds with the sulfonamide structural (SO NH).
    • There may not be any cross-reactivity between antibiotic and non-antibiotic sulfonamides. This is supported by a better comprehension of allergy processes.
    • Non-antibiotic sulfonamides are not likely to cause cross-reactions due to antibody production (anaphylaxis).
    • Less is known about type IV T-cell reactions, such as maculopapular skin rash. Based on what is known at the moment, it is difficult to rule out this possibility.
    • For severe reactions such Stevens Johnson syndrome or toxic epidermal necrolysis, treatment is not advised.
  • Aortic/mitral stenosis:

    • Patients with severe aortic/mitralstenosis should be cautious.
  • Bariatric surgery

    • It is important to avoid diuretics during the first 24 hours after bariatric surgery. They can cause electrolyte imbalance and dehydration.
    • Once the oral fluid intake has been sufficient, diuretics can be resumed.
  • Diabetes:

    • Patients with diabetes mellitus or prediabetes should exercise caution when giving hydrochlorothiazide, as it can cause a change in glucose control.
  • Hepatic impairment

    • Patients should exercise caution when using the medication if they have significant hepatic impairment or biliary blockage.
    • Hepatic encephalopathy/coma can be caused by electrolyte or acid/base imbalances.
  • Hypercalcemia:

    • Thiazides decrease renal calcium excretion so it is not recommended for patients with hypercalcemia.
  • Hypercholesterolemia:

    • Patients with high cholesterol should be cautious when taking Thiazide.
  • Parathyroid disease

    • After receiving long-term thiazide medication, you can observe decreased calcium excretion and pathological alterations in the parathyroid glands linked to hypercalcemia or hypophosphatemia.
    • You should not take the drug until you have tested for parathyroid function.
  • Renal artery stenosis

    • Renal dysfunction risk may be raised by valsartan. It is crucial to use caution while dealing with unilateral or bilateral renal arterial stenosis that is unstented.
    • It is advised to avoid use if there is untreated bilateral renal arterial stenosis unless the advantages outweigh the disadvantages.
  • Renal impairment

    • Anuria is a contraindication to the drug
      • Only severe renal impairment and pre-existing renal disease should be treated with valsartan.
      • Hydrochlorothiazide can precipitate azotemia.
      • If severe renal impairment is observed, the drug should be stopped.
  • Systemic lupus erythematosus (SLE):

    • SLE activation or exacerbation can be caused by hydrochlorothiazide.

Monitoring parameters:

  • Pulse
  • BP
  • Serum electrolytes
  • Renal function tests

How to administer Co Diovan (Valsartan and hydrochlorothiazide)?

  • It should be taken orally with or without food.

Mechanism of action of Valsartan and hydrochlorothiazide (Co Diovan):

  • Valsartan, unlike the ACE inhibitors and direct antagonists of the angiotensin II receptors (AT2), acts by displacing the AT1 receptor with angiotensin II. It lowers blood pressure by antagonizing AT1 vasoconstriction and aldosterone, catecholamine, and arginine vasopressin releases, as well as water intake and hypertrophic reactions. It is more effective than ACE inhibitors and has fewer side effects.
  • Hydrochlorothiazide increases sodium excretion, water, potassium and hydrogen ions. It inhibits sodium reabsorption from the distal tubules.

See Valsartan and Hydrochlorothiazide

International Brands of Valsartan and hydrochlorothiazide:

  • Aralter Plus
  • Cardisar
  • Cardival Plus
  • Co-Aginet
  • Co-Bespres
  • Co-Dio
  • Co-Diopass
  • Co-Diovan
  • Co-Diovane
  • Co-Dopcor
  • Co-Tareg
  • Codiortan
  • CoDiovan
  • Codiqvan
  • Corixil
  • Cotareg
  • Covaratan
  • Detension
  • Diovan Comp
  • Diovan D
  • Diovan HCT
  • Dizantin Plus
  • Duotan
  • Duoval
  • Duovan
  • Dynaval
  • Hapresval Plus
  • Kalpress Plus
  • Maxdioplus
  • Miten Plus
  • Nisisco
  • Sakord H
  • Simultan D
  • Tareg D
  • Tensart HCT
  • V-Van Plus
  • Valazyd-H
  • Valent-H
  • Valsaprex-H
  • Valsartan/HCT
  • Valsotens HCT
  • Valtan H
  • Valtan Plus
  • Valtensin HCT
  • Valzaar-H
  • Vector Plus

Valsartan and hydrochlorothiazide Brand Names in Pakistan:

Valsartan and Hydrochlorothiazide 80/12.5 mg

Amodip-V Mass Pharma (Private) Limited
Co Valtec Tabros Pharma
Co-Diovan Novartis Pharma (Pak) Ltd
Co-Sartan Werrick Pharmaceuticals
Co-Valid Scilife Pharma (Private) Ltd
Dioplus Atco Laboratories Limited
Listan Ht Lexicon Pharmaceuticals (Pvt) Ltd.
Nuval -D Pharmevo (Pvt) Ltd.
Valken-H Kanel Pharmaceuticals

Valsasartan And Hydrochlorothiazide 160/12.5 Mg

Angiotan H Efroze Chemical Industries (Pvt) Ltd.
Co Valtec Tabros Pharma
Co-Diovan Novartis Pharma (Pak) Ltd
Co-Diovan Novartis Pharma (Pak) Ltd
Co-Sartan Werrick Pharmaceuticals
Co-Valid Scilife Pharma (Private) Ltd
Co-Valseta Maple Pharmaceuticals (Pvt) Ltd
Co-Valstar Consolidated Chemical Laboratories (Pvt) Ltd.
Nuval -D Pharmevo (Pvt) Ltd.
Valam-H Consolidated Chemical Laboratories (Pvt) Ltd.